Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Phase 1

Completed

• Conditions: Hepatic Impaired; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: semaglutide

• Registration Number: NCT02210871
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild, moderate or severe hepatic impairment compared to subjects with normal hepatic function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-06
• Study Start: 2014-08-07
• Study First Posted: 2014-08-07
• Primary Completion: 2015-06-03
• Study Completion: 2015-06-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Male or female, age at least 18 years at the time of signing informed consent
• Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)
• Only for subjects with hepatic impairment (mild, moderate and severe): A diagnosis of cirrhosis due to parenchymal liver disease, classified as Child-Pugh grade A,B or C as assessed by investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound,computerised axial tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy
• Only for subjects with normal hepatic function: Subjects who are judged to be in good general health based on physical examination, medical history, ECG, vital signs, and the results of biochemistry, coagulation, haematology tests and urinalysis performed during the screening visit, as judged by the investigator

Exclusion Criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including the follow-up period (adequate contraceptive measures as required by local regulation or practice)
• Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement at the screening visit is allowed
• Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with trial procedures
• Donation of any blood or plasma in the past month or in excess of 400 mL within the 3 months preceding screening, or surgery or trauma with more than 400 mL blood loss within the 3 months preceding screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal hepatic function	semaglutide	-
Mild hepatic impairment	semaglutide	-
Severe hepatic impairment	semaglutide	-
Moderate hepatic impairment	semaglutide	-

Primary Outcome Measures

Name	Time	Method
Area under the semaglutide plasma concentration-time curve	Day 1 - day 36

Secondary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	Day 1 - day 36
Maximum observed semaglutide plasma concentration	Day 1 - day 36

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Bratislava, Slovakia